MAUDE Adverse Event Report: DEROYAL INDUSTRIES UMBILICAL CORD CLAMP; DEVICE, OCCLUSION, UMBILICAL

Catalog Number 6833-B

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2012

Event Type  malfunction  

Event Description

The clamp ends are not meeting when closing clamp.

Manufacturer Narrative

Investigation findings: deroyal is the manufacturer of finished good 6833-b, umbilical cord clamp 1000/cs, which has a report of "there have been a number of clamps where the ends are not meeting when they are trying to close the clamps." the work order review identified the raw material and lot number in reference to the report.Raw material (b)(4)lot number 11112631, was identified.The raw material is a vendor supplied product.The vendor, (b)(4), was issued (b)(4) for the report.The samples were received and forwarded to (b)(4) to assist in the investigation.(b)(4) issued the (b)(4) response on 11/12/2012.In addition, the qc complaint specialist reviewed the sales information, call history logs, and scar logs.Deroyal has sold (b)(4) cases of finishing good 6833-b from 2011 to current.The call history logs and scar logs review found no similar reports for the finished good or raw material (b)(4).Correction (action taken to correct the issue and contain the problem): two cases of replacement product were shipped on order #(b)(4).Root cause analysis (why did problem occur?): the lot history record for the reference lot was reviewed and it was confirmed that the lot met all specifications prior to release.The samples returned for evaluation were visually inspected, and no defects were identified.The samples provided closed and latch with no problem.A recent study conducted by engineering, where cord clamps where submitted to a series of tests revealed that during testing, no failures were observed of either the latching mechanism or hinge.Corrective action and/or systemic correction action taken (these are actions for the existing issue.): as a result of the engineering study, an opportunity for improvement was identified.A curve to the tooth profile was decreased from a radius of 19.1 inches to a radius of 11 inches.This adds to the closing force and keeps more pressure in the center of the clamp.A secondary change was adding.015 inches of height to the back rib to have a slightly higher closing force.Thi was documented and approved in engineering change order (b)(4).The first lot after the mentioned improvement is lost (b)(4).Updated: due to the investigation and root cause determination a preventive action has not been taken.This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides information which changes the content of this report.

• Brand Name: UMBILICAL CORD CLAMP
• Type of Device: DEVICE, OCCLUSION, UMBILICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES; 700 martin luther king, jr. blvd; sanford FL 32771
• Manufacturer (Section G): CRITICAL DISPOSABLES, INC.; 700 bevier rd.; sanford FL 32771
• Manufacturer Contact: 700 bevier rd.; sanford, FL 32771
• MDR Report Key: 4749177
• MDR Text Key: 5824033
• Report Number: 1033554-2015-00006
• Device Sequence Number: 1
• Product Code: FOD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2017
• Device Catalogue Number: 6833-B
• Device Lot Number: 28843739
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2012
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention